ABSTRACT
The hydrogen peroxide vapor sterilization cycle consists of the dry phase, the leak test phase, the sterilize phase, and the aeration phase. The sterilization phase consists of an even number of sterilize pulses. Triplicate runs should be made during the validation of each of the individual phases, except for the sterilization phase where a triplicate half-sterilize phase and a triplicate full-sterilize phase should both be run. The purpose of the sterilize phase is to effect sterilization by exposing the interior of the freeze dryer to H2O2 vapor sterilant while controlling all parameters that can affect the sterilization process. Minimal particulate matter should be in the lyophilizer at the beginning of the aeration phase because of the purging during the dry phase and the sterilize phase. The accurate means for measuring H2O2 concentration within the enclosure during sterilization will simplify and improve the validation process, continual verification, and even feedback and control systems for the sterilization equipment itself.
